Gabapentin for the Treatment of Tinnitus

This study has been terminated.

First Received on April 21, 2006. Last Updated on March 17, 2010 History of Changes

Sponsor:	Washington University School of Medicine
Collaborator:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00317850

Purpose

The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.

Condition	Intervention	Phase
Tinnitus	Drug: Gabapentin (Neurontin)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary Outcome Measures:

Beck Depression Inventory Score from Baseline to Week 8
Brief Symptom Inventory Score from Baseline to Week 8
Epworth Sleepiness Scale Score from Baseline to Week 8

Estimated Enrollment:	160
Study Start Date:	April 2004
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adults, between the ages of 18 and 70
Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater
Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.

Exclusion Criteria:

The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled.
Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance.
Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
Patients with any serious or unstable medical or psychiatric condition.
Patients whose ability to give informed consent is in question.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317850

Sponsors and Collaborators

Washington University School of Medicine

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Jay F Piccirillo, MD

Washington University School of Medicine

More Information

Additional Information:

Clinical Outcomes Research Office at the Washington University School of Medicine This link exits the ClinicalTrials.gov site

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7.

ClinicalTrials.gov Identifier:	NCT00317850 History of Changes
Other Study ID Numbers:	R01 DC006253-01, R01DC006253
Study First Received:	April 21, 2006
Last Updated:	March 17, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 12, 2012